PROJECT SUMMARY 1 Alopecia areata (AA) causes loss of hair on the scalp and the body1-2, interferes with daily activities, 2 and has visual and emotional impacts (e.g., feelings of embarrassment and self-consciousness) that 3 are life limiting and only measurable by the patient3-7. In clinical trials, however, AA treatment efficacy 4 is typically evaluated using clinician-reported outcome (ClinRO) measures8. While ClinRO?s are 5 important, patient reported outcomes (PRO?s) are also valuable and can provide a more 6 comprehensive understanding of treatment effects in clinical trials9-11. Unfortunately, while measures 7 exist to assess the patient perspective in AA clinical studies7, supporting information suggest gaps in 8 their development history relative to the Food and Drug Administration (FDA) PRO Guidance9-11. For 9 these reasons, the FDA identified the need to develop patient centered trial assessments and 10 endpoints to better understand new AA treatment effects12. 11 In response to this need, the National Alopecia Areata Foundation (NAAF) formed a multi-stakeholder 12 Consortium to develop the Hair Assessment of Impact and Reported Satisfaction (HAIRS v3.0; 13 Appendix A), a PRO instrument to evaluate AA treatment benefit from the patient perspective (DDT 14 COA 000101). Developed in ways consistent with FDA guidance9-11, the HAIRS v3.0 was informed by 15 a literature review, input from therapeutic area experts (n=6), and concept elicitation (n=42) and 16 cognitive debriefing (n=30) interviews with clinically confirmed AA patients. The HAIRS v3.0 is 17 conceptualized to assess patient reported: 1) satisfaction with scalp hair (5 items); 2) satisfaction with 18 eyebrow, eyelash, and other body hair (3 items); 3) impact of alopecia on behavior (i.e., an indicator of 19 patient function) (2 items); and 4) impact of alopecia on emotional self-perceptions (i.e., an indicator 20 of patient feelings) (4 items). 21 Throughout the HAIRS v3.0 development, the NAAF has communicated with the FDA?s Qualification 22 Review Team (QRT) as developers seek use of the assessment in regulated clinical trials to support 23 product approval and labeling goals. Over four separate consultations with the QRT, various revisions 24 to the HAIRS have resulted. Given the nature and extent of these modifications, and the importance 25 of consistent respondent interpretation to COA content, a second round of cognitive interviews will be 26 necessary to test the revised HAIRS v3.0 prior to its quantitative (i.e., psychometric) evaluation. The 27 purpose of this grant application is to secure the funding necessary to support the continued 28 development of the HAIRS v3.0 in terms of (1) evaluating questionnaire content; (2) designing a study 29 for its psychometric evaluation; and (3) developing the ongoing regulatory documentation for the QRT 30 consideration. Project Summary Page 1